Changes in Pituitary Iron and Volume With Deferasirox
1 other identifier
observational
130
1 country
1
Brief Summary
Despite continuing advances in iron chelation therapy, iron toxicity of endocrine glands, particularly the pituitary gland, remains common in patients with transfusion dependent anemias. We would like to establish accurate population norms of pituitary R2 and volume and understand the progression of pituitary iron in transfused patients on Deferasirox.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 17, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedOctober 31, 2023
October 1, 2023
2.7 years
June 17, 2011
October 27, 2023
Conditions
Study Arms (2)
Chronically Transfusion Patients
Patients with transfusion dependent anemia (excluding sickle cell disease), ages 2-25, on Deferasirox chelation therapy, to be monitored over 2 years.
Controls
Normal controls, ages 2-25, with no known brain abnormality or endocrine dysfunction.
Eligibility Criteria
Transfusion Dependent Anemia
You may qualify if:
- Currently on chronic transfusion therapy.
- Duration of chronic transfusion \>1 year.
- Age 2 to 25 years
- On deferasirox monotherapy for the duration of the study.
- Informed consent from legal guardian and/or patient.
- On deferasirox for a minimum of 3 months at start of study.
You may not qualify if:
- Sickle cell disease or sickle-beta zero genotype.
- Combination of deferasirox and another iron chelator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Los Angeleslead
- Novartis Pharmaceuticalscollaborator
Study Sites (1)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Related Publications (1)
Wood JC, Noetzl L, Hyderi A, Joukar M, Coates T, Mittelman S. Predicting pituitary iron and endocrine dysfunction. Ann N Y Acad Sci. 2010 Aug;1202:123-8. doi: 10.1111/j.1749-6632.2010.05545.x.
PMID: 20712782RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John C Wood, MD, PhD
Children's Hospital Los Angeles
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 17, 2011
First Posted
June 20, 2011
Study Start
November 1, 2008
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
October 31, 2023
Record last verified: 2023-10